Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV

NCT02267018 | Completed

• 1 other identifier: 001-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always provide enough support. A new option is non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with gas exchange and may decrease a baby's work of breathing. The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

nCPAP; High-Frequency Oscillator Ventilation; Diaphragm Electrical Activity

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the difference in the peak electrical activity of the diaphragm between nCPAP and NIHFV.

  Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP and NIHFV).

  4 hours

Secondary Outcomes (5)

• Difference in neural respiratory rate.

  4 hours

• Difference in neural inspiratory time.

  4 hours

• Difference in diaphragm energy expenditure.

  4 hours

• Difference in transcutaneous pCO2.

  4 hours

• Number of apnea episodes.

  4 hours

Study Arms (2)

nCPAP

ACTIVE COMPARATOR

Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants.

Device: Drager VN500 Ventilator

NIHFV

ACTIVE COMPARATOR

Non-invasive high-frequency ventilation is a relatively new modality that is being utilized to support preterm infants and prevent the need for invasive ventilation, but this particular modality is has not been well studied to date.

Device: Drager VN500 Ventilator

Interventions

Drager VN500 Ventilator DEVICE

This ventilator is capable of providing both nCPAP and NIHFV support.

NIHFV; nCPAP

Eligibility Criteria

• Age: 2 Days - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinically stable preterm infants with birth weights ≤1500g admitted to the neonatal intensive care unit (NICU) at Sunnybrook Health Sciences Centre or BC Women's and Children's Hospital.
• Patient's on nasal continuous positive airway pressure of 6 to 8 cmH20 support for at least 48 hours, treated with methylxanthines for apnea of prematurity and requiring 25-40% of oxygen.

You may not qualify if:

• infants with congenital anomalies of the gastrointestinal tract, phrenic nerve damage, diaphragmatic paralysis, esophageal perforation;
• infants with congenital or acquired neurological deficit (including significant intraventricular hemorrhage \>Grade II) \[27\], neonatal seizure;
• infants with significant congenital heart disease (including symptomatic PDA);
• infant with congenital anomalies of the diaphragm;
• infant with congenital anomalies of the respiratory tracts (e.g. Congenital Cystic Adenomatoid Malformation (CCAM)) infants requiring ongoing treatment for sepsis, necrotizing enterocolitis (NEC), antibiotics for lung infections, narcotic analgesics, or gastric motility agents will be excluded.
• infants on nasal CPAP and requiring more than 40% oxygen will be excluded from the study.
• infants with significant gastric residuals and vomiting, infants with facial anomalies, infants with pneumothorax or pneumomediastinum, and infants in the immediate postoperative period will be excluded.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Dunn, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neonatologist

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: August 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)